BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEART™

    FDA UDI
    SUNMED, LLC·10889483223734·HEART™ Direct Connect Continuous Nebulizer, Adu...

    Heart® Direct Connect Continuous Nebulizer,Adult Kit

    FDA UDI
    WESTMED, INC.·00709078000119·Heart® Direct Connect Continuous Nebulizer,Adul...

    WEITLANER RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048546·WEITLANER RETRACTOR BLUNT TIPS

    HS Matchstick Bur,Ø1.8x150,80K

    FDA UDI
    Bien-Air Surgery SA·17630055507607·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450187494·

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361005629·Arena-L, Lordotic 10 degrees, 38X28X19

    KING SEPTEMS

    FDA Adverse Event
    Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

    UCLA AND UNIVERSAL ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    SCANDINAVIAN IVF SCIENCES AB, G2.2

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 28, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 8, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·May 17, 2011

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025